Kornimate/medical-research-clean huggingface dataset:
contrast echocardiography during exercise to assess pulmonary blood volume

Conditions: Heart Failure; Pulmonary Vascular Disease

Summary: the purpose of this study is to evaluate whether pulmonary blood volume (pbv) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (pawp) during exercise. also, to compare changes in pbv with exercise in patients with and without heart failure and pulmonary vascular disease.


Eligibility criteria:
inclusion criteria: * patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. investigators will include patients with normal or low ef, and across the spectrum of pulmonary hypertension severity. exclusion criteria: * patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case. * prior adverse reaction to echo contrast administration
improving maternal cardiovascular outcomes through the implementation of a hypertensive disorders of pregnancy bundle in nigeria

Conditions: Hypertensive Disorder of Pregnancy

Summary: the goal of this interventional study is to learn from patients and healthcare providers at 4 health institutions (study sites) in abuja and kano in nigeria what ways to best develop the content of a hypertensive disorders of pregnancy ( hdp) management package for pregnant women, and evaluate the effectiveness of implementing this package in improving cardiovascular health of pregnant women. the main question it aims to answer is: will a contextualized home bp monitoring program lead to better bp control among patients with hdp in nigeria?

this study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability and effectiveness of: 1) postpartum remote blood pressure monitoring, 2) patient education, 3) development of a standardized postpartum follow-up protocol, and 4) provision of free and/or subsidized antihypertensive medications for patients with hdp in university of abuja, murtala muhammad specialist hospital, national hospital, abuja and aminu kano teaching hospital all in nigeria. these components collectively make up a contextualized postpartum bp monitoring program called the hdp implementation bundle. the long-term objective is to implement a contextualized and acceptable evidence-based postpartum home bp monitoring program with supporting services and components, at 4 tertiary care institutions in nigeria, to improve postpartum bp control in patients with hdp using a multilevel approach.

Eligibility criteria:
inclusion criteria: * postpartum adults (\>18 years) * postpartum emancipated minors (in accordance with the nigerian guidelines for young persons' participation in research and reproductive health services) * with diagnosis of hdp prior to delivery delivered at one of the participating sites able to provide informed consent. exclusion criteria: * unable to provide consent.

Keywords: hypertension pregnancy preeclampsia hdp
an investigational immuno-therapy study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy in virus-associated tumors

Conditions: Various Advanced Cancer

Summary: the purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. certain viruses have been known to play a role in tumor formation and growth. this study will investigate the effects of the study drugs, in patients who have the following types of tumors: * anal canal cancer-no longer enrolling this tumor type * cervical cancer * epstein barr virus (ebv) positive gastric cancer-no longer enrolling this tumor type * merkel cell cancer * penile cancer-no longer enrolling this tumor type * vaginal and vulvar cancer-no longer enrolling this tumor type * nasopharyngeal cancer - no longer enrolling this tumor type * head and neck cancer - no longer enrolling this tumor type


Eligibility criteria:
inclusion criteria: * histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types): 1. merkel cell carcinoma 2. gastric or gastro-esophageal junction carcinoma (no longer enrolling this tumor type) 3. nasopharyngeal carcinoma 4. squamous cell carcinoma (scc) of the cervix, vagina, or vulva 5. squamous cell carcinoma of the head and neck 6. squamous cell carcinoma of the anal canal and penis 7. recurrent/metastatic scc of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer combination b expansion cohort * measurable disease by ct or mri * eastern cooperative oncology group (ecog) performance status of 0 or 1 * patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen) * men and women of age 18 or older exclusion criteria: * active brain metastases or leptomeningeal metastases * patients with active, known or suspected autoimmune disease * patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * patients with hepatitis * patients with hiv * pregnant or breastfeeding women
analysis of the variation in caspase-8 availability and cleavage in oral squamous cell carcinoma

Conditions: Oral Cancer

Summary: control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. caspase-8 is a key enzyme involved in controlling cell death. this study examines the importance of caspase-8 in oral cancer.

control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. the caspase family of enzymes are the key performers of controlled cell death and caspase-8 is frequently mutated in oral cancer. this study will perform dna sequencing to determine if the gene is wild-type (not mutated). the abundance of inactive (uncleaved) and active (cleaved) caspase-8 will be determined. the levels of the proteins that caspase-8 interacts with (including caspase-3) will be determined. results will be correlated with tumour stage, patient outcome and the presence of immune cells and other microscopic features. this will improve the understanding of the importance of caspase-8 in oral cancer.

Eligibility criteria:
inclusion criteria: * oral cancer * sufficient follow up data exclusion criteria: * patient has indicated that they do not wish their tissue to be used for research. * . the quantity or quality of tissue is too little or poor to provide adequate material without significant reserve. * the material contains bone.
does optimized general anesthesia care reduce postoperative delirium?

Conditions: Hip Fractures; Anesthesia; Delirium

Summary: postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. to date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. this prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.

subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) optimal care - the intraoperative depth of anesthesia will be directed using a bis monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained \> 60% during anesthesia. subjects will be evaluated using the confusion assessment method (cam) for the first 5 postoperative days to determine if they experience postoperative delirium.

Eligibility criteria:
inclusion criteria: * subject or legal representative has voluntarily signed the informed consent approved by the institutional review board, * hip fracture surgery scheduled under general anesthesia * subject is 65 years or older on the day of surgery exclusion criteria: * inability to follow directions or comprehend the english language * severe uncorrected visual or auditory handicaps * delirium at screening or baseline * emergency surgery
effects of adaptive physical activity on health-related fitness of students with intellectual disabilitiesdisability

Conditions: Intellectual Disability

Summary: the object of this study is the theory and practice of adaptive physical activity for people with intellectual disability. it focuses on the concepts, paths, and applications of adaptive physical activities for young people with intellectual disability, and systematically studies and discusses the concepts, paths, and application strategies of adaptive physical activities for young people with intellectual disability, so as to provide solutions and support for the scientific exercise of this special population group. the study will focus on the following four aspects: (1) theoretical research on the interventions of young people with intellectual disability (2) analysis of the sports and health needs of young people with intellectual disability (3) empirical research on adaptive physical activities for young people with intellectual disability (4) exploration of strategies for the use of adaptive physical activities. based on theoretical and practical research, to understand the current situation of sports participation and influencing factors of effects of adaptive physical activity on health-related fitness and fundamental movement skills in students with intellectual disability , to provide a reliable basis for the formulation of adaptive sports activity programmes suitable for the rehabilitation concepts of the effects of adaptive physical activity on health-related fitness and fundamental movement skills in students with intellectual disability; to increase the interest of effects of adaptive physical activity on health-related fitness and fundamental movement skills in students with intellectual disability in sports activities, so as to enable them to master the basic sports skills, have the physical abilities required for completing the basic social activities, and be able to participate in sports activities on a regular basis in their future lives; and to promote their physical health and happy lives, with a view to facilitating their integration into regular education and, ultimately, social integration.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of intellectual disability * agree and promise to participate in the exercise intervention throughout the study programme * no other physical activity other than participation in school sports exclusion criteria: * have other medical conditions that limit physical activity (e.g. asthma, heart disease, etc.) * suffers from complex neurological disorders * unable to play sports due to abnormal physical development

Keywords: intellectual disability health-related fitness fundamental movement skills
xrb vs. slb in jail and at re-entry: pilot, proof of concept

Conditions: Opioid Dependence

Summary: this is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.


Eligibility criteria:
inclusion criteria: * adults \>18yo incarcerated in nyc jails with known release dates. * dsm-v criteria for current opioid use disorder (dsm-iv opioid dependence). * currently maintained on sublingual buprenorphine-naloxone in the nyc jail opioid treatment program. exclusion criteria: * individual not interested in xrb treatment. current slb patients are otherwise by definition appropriate for xrb. * pregnant or planning conception. a urine dipstick pregnancy (hcg) test will be administered at baseline. the test detects human chorionic gonadotropin (hcg) in urine with a sensitivity/specificity of: 25 miu hcg/ml, \>99%. time to result is four minutes. if negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant * no severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.

Keywords: opioid dependence buprenorphine primary care treatment extended-release buprenorphine
prospective clinical study to evaluate the efficacy of the stand-alone cervical interbody cage c-curve ( titanium) manufactured by medicrea®

Conditions: C-CURVE , Cervical Interbody Cage; Cervical Disc Disease; Cervical Discopathy

Summary: this study includes one type of product named c-curve which is a stand-alone cervical interbody cage. this product is available in two materials: peek and titanium. the c-curve cervical interbody devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). c-curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. this system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). this system must only be used in the cervical spine. this post-market clinical follow-up (pmcf) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the ce mark through a clinical evaluation.


Eligibility criteria:
inclusion criteria: * patient operated with c-curve titanium (medicrea) for one or several levels (3 maximum) * cage implanted with the bone graft "osmosys" (medicrea) or an auto bone graft from patients * patient ≥ 18 years * patient affiliated to health care insurance (social security in france) * patient who signed an informed consent form * patient able and willing to complete a self-administered questionnaire * patient able to understand protocol and the planning visit and willing to perform all of them * patient with a pathology indicated in the instruction for use of the implant exclusion criteria: * patient with no preoperative data available (x-rays, questionnaires) * hybrid installation or cervical additional fixation * patient contraindicated for x-ray(s) and/or ct-scan(s) * patient with contraindications indicated in the instruction for use of the implant * patient judged as non-compliant by the investigator, not unable to come back for the follow-up visits (for example: patient living more than 100 km away). * patient who declined to participate to the study or unable to give his consent vulnerable population as explained in the protocol

Keywords: cervical disc disease cervical disc degeneration c-curve , cervical interbody cage
long-term observational study to evaluation the safety of furestem-ra inj

Conditions: Rheumatoid Arthritis

Summary: observational study to evaluate the safety of furestem-ra lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of furestem-ra lnj.

this is a observational study, single center, open label, study of safety of furestem-ra inj. in subjects with moderate to severe rheumatoid arthritis. subjects participating in this observational study originally participated in study furestem-ra inj. \[nct02221258\]

Eligibility criteria:
inclusion criteria: * subjects participating in this observational study originally participated in study furestem-ra inj.\[nct02221258\] * subject who understands and voluntarily sign an informed consent form exclusion criteria: * in case follow-up is not possible from end of clinical trial phase 1 to end of this study period

Keywords: furestem-ra
tofacitinib combined with chidamide in r/r enktcl

Conditions: Extranodal NK/T-cell Lymphoma

Summary: this study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal nk/t cell lymphoma.


Eligibility criteria:
inclusion criteria: * 1. patients with primary refractory or recurrent extranodal nk/t cell lymphoma that do not qualify for treatment protocols of higher priority. 2. adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dl. 3. adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (sgot) and/or serum glutamate pyruvate transaminase (sgpt) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal. 4.. adequate cardiac function with left ventricular ejection fraction \>/= 50%. no uncontrolled arrhythmias or symptomatic cardiac disease. 5. performance status 0-1. 6. negative beta diffusing capacity of lung for carbon monoxide (hcg) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization exclusion criteria: -1. patients relapsed after allogeneic stem cell transplant 2. patients with active hepatitis b or c(hbv dna \>/=10,000 copies/ml). 3. active infection requiring parenteral antibiotics 4. hiv infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (cd4) counts 5. evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis c or positive hepatitis c serology. 6. patients with a cqt longer than 500 ms
validation of the mbi-c scale in french

Conditions: Subjective Cognitive Complaint; Mild Cognitive Impairment; Neuropsychiatric Symptoms

Summary: this study aims to validate the french version of the mild behavioral impairment-checklist (mbi-c) scale, hypothetically effective for measuring behavioral symptoms in patients presenting with a subjective cognitive complaint or mild cognitive impairment (mci).

neuropsychiatric symptoms are common in the prodromal stage of dementia and may precede cognitive impairment. their presence in patients without cognitive impairment, but with a subjective cognitive complaint or mild cognitive impairment (mci), is associated with an increased risk of progression to dementia. the concept of mild behavioral impairment (mbi) was developed to identify populations at risk from the early stages of the disease. mbi is characterized by long-lasting psychiatric symptoms appearing late, in patients without cognitive deficits or with mci, and can precede dementia. the general hypothesis is that the french version of the mild behavioral impairment-checklist (mbi-c) scale has good psychometric capabilities to correctly measure behavioral symptoms in patients with subjective cognitive complaint or mci. the main objective is to verify the reliability and internal and external validity of the mbi-c score. secondary objectives include studying the prevalence of mbi and determining the best cutoff for the diagnosis of mbi in patients with mbi or subjective cognitive complaint. this is an observational, national, multicenter and cross-sectional study. it will include 170 patients (5 per scale item, or 34 items), with an inclusion period of 24 months and a total research duration of 25 months. patients must be over 50 years old, have had subjective cognitive complaint or mild cognitive impairment for at least 6 months, and have a person who visits them at least once a week. validation of the mbi-c scale in french could play a crucial role in the identification and early management of neurodegenerative disorders.

Eligibility criteria:
inclusion criteria: * patient presenting a subjective cognitive complaint (scp) or mild cognitive impairment (mci) for at least 6 months. * patient with a relative visiting them at least once a week. * no opposition from the patient and his loved one exclusion criteria: * patient presenting criteria for major neurocognitive disorder according to dsm-v criteria. * neuropsychiatric symptoms secondary to concomitant treatments, or to a medical or psychiatric pathology. * concomitant major depressive episode (dsm-v). * presence of concomitant pathologies preventing participation in the study (taking tests).
different volumes of durolane in knee oa

Conditions: Knee Osteoarthritis

Summary: the purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of durolane in patients with knee oa.

to assess the safety and efficacy profiles of different volumes of durolane in patients with knee oa and compare with the current standard single-injection of the product. the study aims to investigate whether different volumes of durolane compared to the standard injection volume will improve the benefit/risk profile.

Eligibility criteria:
inclusion criteria: * subject (female or male) * 40-85 years of age * unilateral knee pain fulfilling american college of rheumatology (acr) criteria for diagnosis of osteoarthritis(oa) * radiographic evidence of oa in the study knee * womac pain score of 7-17 in the study knee * womac pain score of 2-3 in the study knee (womac likert 3.1 a1) * subject normally active * subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics * subject cooperative and able to communicate effectively with the investigators * body mass index ≤ 35 kg/m2; * signed informed consent obtained exclusion criteria: * knee effusion * contralateral knee oa * clinically significant joint pain from joints other than the knee * previous intra-articular steroid injection into the study knee within the last 6 months * previous intra-articular hyaluronic acid (ha) injection into the study knee within the last 9 months * previous allergic type reaction to a ha product * treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit * use of analgesics 48 hours preceding the baseline visit * use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months * treatment with glucosamine/chondroitin sulfate initiated within the past 3 months * change in physical therapy for the knee within the last three months * arthroscopy or other surgical procedure in the study knee within the past 12 months * serious injuries to the study knee in the past * any planned arthroscopy or other surgical procedure during the study period * previous history or presence of active septic arthritis * active skin disease or infection in the area of the injection site * systemic active inflammatory condition or infection * bleeding diathesis or use of anticoagulants * history of drug or alcohol abuse within 6 months * any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion * pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception * involvement in other clinical trials